Neuropathic PainNCT07487610
Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
An observational study of Neuropathic Pain and Old Age; Debility, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the frequency of neuropathic pain in individuals aged 80 years and older and to evaluate the relationship between neuropathic pain and comprehensive geriatric assessment parameters. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Neuropathic Pain, Old Age; Debility, Pain
- What is being tested?
- Detailed geriatric assessment
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 80 and over who are followed up from the healthy aging outpatient clinic of Edirne Sultan 1. Murat State Hospital geriatric clinic will be included in the study
Who may be able to join
- Age 80 years or older
- Full cooperation
- Complete comprehensive geriatric assessment parameters
Who cannot join
- Patients with dementia classified as CDR-2 or CDR-3 according to the Clinical Dementia Rating (CDR) Scale
- Patients who have experienced an acute illness within the last 1 month (e.g., infection, fracture, or cerebrovascular disease)
- Patients with a psychotic disorder
- Patients with severe hearing loss
- Patients with a history of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
This study aimed to determine the frequency of neuropathic pain in individuals aged 80 years and older and to evaluate the relationship between neuropathic pain and comprehensive geriatric assessment parameters.
- Conditions
- Neuropathic Pain, Old Age; Debility, Pain
- Being tested
- Detailed geriatric assessment
- Medical subject headings
- Neuralgia, Frailty, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed geriatric assessmentOther
The patients' demographic characteristics, comorbid diseases, and laboratory parameters routinely requested from each patient within the last 3 months, including TSH, vitamin D, vitamin B12, HbA1c, hemoglobin, folic acid, and GFR levels, will be recorded.
During the outpatient clinic visit, the presence of neuropathic pain will be assessed using the Douleur Neuropathique-4 (DN4) questionnaire. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and the average pain severity over the last week will be recorded. The use of medications that may affect pain severity and that have been used regularly by the patients for the last 3 months will also be assessed (antiepileptics, nonsteroidal anti-inflammatory drugs, paracetamol, and antidepressants).
The patients will undergo mood assessment, evaluation of basic and instrumental activities of daily living, neurocognitive assessment, frailty assessment, and nutritional assessment.
| Study group | Role | What they receive |
|---|---|---|
| patients without neuropathic pain | Patients with a total score of 4 or higher according to the Douleur Neuropathique 4 (DN4) Receives: Other: Detailed geriatric assessment | |
| Patients without neuropathic pain | Patients with a total DN4 score below 4 Receives: Other: Detailed geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of neuropathic pain
The presence of neuropathic pain will be assessed using the Douleur Neuropathique-4 (DN4) questionnaire. The DN4 consists of 10 items. The first 7 items evaluate the characteristics and sensory quality of pain, whereas the remaining 3 items are based on physical examination findings. A total score of 4 or higher is defined as the presence of neuropathic pain, while a score below 4 is defined as the absence of neuropathic pain.
Measured: Baseline
Secondary outcomes (7)
Pain intensity
Patients' pain intensity will be assessed using the Visual Analog Scale (VAS). In the VAS assessment, a 10-cm horizontal straight line will be used, where 0 indicates no pain and 10 indicates unbearable pain. Using the VAS, the average pain intensity during the last week will be recorded.
Measured: Baseline
Mood status
Mood status will be assessed using the short form of the Yesavage Geriatric Depression Scale. The short form consists of 15 questions to which patients respond with "yes" or "no." Scoring is based on the number of depressive responses, and the total score is used to determine the level of depression. Scores of 0-9 are considered "normal," scores of 10-19 indicate "mild depression," and scores of 20-30 indicate "severe depression.
Measured: Baseline
Daily living activities
The assessment of daily living activities will be assessed with the Lawton-Brody Instrumental Activities of Daily Living Scale (IADLS). IADLS consists of 8 questions that include information on using the telephone, preparing meals, shopping, doing daily housework, doing laundry, being able to get on a vehicle, being able to use medications, and managing money. 0-8 points are evaluated as "dependent," 9-16 points as "semi-dependent," and 17-24 points as "independent."
Measured: Baseline
Activities of daily living
The assessment of daily living activities will be assessed with the the Barthel Index (BI) scale. BI consists of 10 questions that evaluate feeding, washing, self-care, dressing, defecation control, urinary control, going to the toilet, the ability to get from bed to a wheelchair, mobility status such as walking or being wheelchair dependent, and climbing stairs. 0-20 points are considered as completely dependent, 21-61 points as severely dependent, 62-90 points as moderately dependent, 91-99 points as slightly dependent, and 100 points as completely independent.
Measured: Baseline
Neurocognitive assessment
Neurocognitive assessment will be done with Mini Mental State Examination (MMSE). MMSE test is a short screening test with 11 questions and 30 points. MMSE is completed in approximately 10 minutes and evaluates orientation, memory, attention, calculation, recall, language, motor function and perception, visual-spatial abilities. 24-30 points is normal, 18-23 points is mild dementia, 17 and below is compatible with severe dementia.
Measured: Baseline
Frailty
Frailty will be assessed using the Clinical Frailty Scale (CFS). CFS is graded from 1 to 9. The higher the score, the greater the frailty.
Measured: Baseline
Nutritional assessment
Nutritional assessment will be evaluated with the Mini Nutritional Assessment questionnaire-short form (MNA-SF). MNA-SF consists of 5 subheadings; those with 12-14 points are considered "no risk of malnutrition", those with 8-11 points are considered "at risk of malnutrition" and those with 0-7 points are considered "malnourished".
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start17 Mar 2026
- Primary completion30 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan 1. Murat State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alper Mengi, Sultan 1. Murat State Hospital
- Investigators
- Kübra Altunkalem Seydi, MD, Principal investigator, Sultan 1. Murat State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487610
- Sponsor's protocol ID
- 29/12/2025-Number:13/33
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested, the data of the study will be shared by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older
- ClinicalTrials.gov ID
- NCT07487610
- Acronym / sponsor ID
- 29/12/2025-Number:13/33
- Conditions
- Neuropathic Pain, Old Age; Debility, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Sultan 1. Murat State HospitalOther government
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the frequency of neuropathic pain in individuals aged 80 years and older and to evaluate the relationship between neuropathic pain and comprehensive geriatric assessment parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients without neuropathic pain | – | Other: Detailed geriatric assessmentPatients with a total score of 4 or higher according to the Douleur Neuropathique 4 (DN4) |
| Patients without neuropathic pain | – | Other: Detailed geriatric assessmentPatients with a total DN4 score below 4 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 80 and over who are followed up from the healthy aging outpatient clinic of Edirne Sultan 1. Murat State Hospital geriatric clinic will be included in the study
Key inclusion criteria (3 listed)
- Age 80 years or older
- Full cooperation
- Complete comprehensive geriatric assessment parameters
Key exclusion criteria (5 listed)
- Patients with dementia classified as CDR-2 or CDR-3 according to the Clinical Dementia Rating (CDR) Scale
- Patients who have experienced an acute illness within the last 1 month (e.g., infection, fracture, or cerebrovascular disease)
- Patients with a psychotic disorder
- Patients with severe hearing loss
- Patients with a history of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detailed geriatric assessmentThe patients' demographic characteristics, comorbid diseases, and laboratory parameters routinely requested from each patient within the last 3 months, including TSH, vitamin D, vitamin B12, HbA1c, hemoglobin, folic acid, and GFR levels, will be recorded. During the outpatient clinic visit, the presence of neuropathic pain will be assessed using the Douleur Neuropathique-4 (DN4) questionnaire. Pain intensity will be evaluated using the Visual Analog Scale (VAS), and the average pain severity over the last week will be recorded. The use of medications that may affect pain severity and that have been used regularly by the patients for the last 3 months will also be assessed (antiepileptics, nonsteroidal anti-inflammatory drugs, paracetamol, and antidepressants). The patients will undergo mood assessment, evaluation of basic and instrumental activities of daily living, neurocognitive assessment, frailty assessment, and nutritional assessment. | Other | Patients without neuropathic pain, patients without neuropathic pain |
Primary outcome
Presence of neuropathic pain
Time frame: Baseline
The presence of neuropathic pain will be assessed using the Douleur Neuropathique-4 (DN4) questionnaire. The DN4 consists of 10 items. The first 7 items evaluate the characteristics and sensory quality of pain, whereas the remaining 3 items are based on physical examination findings. A total score of 4 or higher is defined as the presence of neuropathic pain, while a score below 4 is defined as the absence of neuropathic pain.
7 secondary outcomes
Pain intensity
Time frame: Baseline
Mood status
Time frame: Baseline
Daily living activities
Time frame: Baseline
Activities of daily living
Time frame: Baseline
Neurocognitive assessment
Time frame: Baseline
Frailty
Time frame: Baseline
Nutritional assessment
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. If requested, the data of the study will be shared by the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kübra Altunkalem Seydi, MD principal investigator
Sultan 1. Murat State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Old Age; Debility, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of neuropathic pain (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.